haemophilia A – media

Seven medicines leap closer to EU approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
- Source: pharmatimes
- 1,023
- January 30, 2018
CHMP diabetes EMA haemophilia A Hemlibra polices Roche
EU nod for Shire’s longer-acting haemophilia A therapy

Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
- Source: Pharmatimes
- 543
- January 18, 2018
Adynovi haemophilia A New Approvals
FDA clears Shire’s dosing software for haemophilia A SHARE

Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).
- Source: medicaldevice-network
- 609
- December 26, 2017
ADVATE FDA haemophilia A Shire

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